Endologix AFX2 Anatomically Fixated Endograft Compared to Proximally Fixated Endografts in LEOPARD at 5 Years

November 4, 2022—Five-year results of the LEOPARD trial demonstrated that the AFX2 anatomically fixated endograft (Endologix LLC) has similar outcomes to commercially available proximally fixated endografts in endovascular aneurysm repair (EVAR) procedures.

The postmarket LEOPARD—Looking at EVAR Outcomes by Primary Analysis of Randomized Data—trial is a prospective randomized clinical trial designed to compare relevant clinical outcomes after EVAR using contemporary commercially available devices.

Christopher J. Kwolek, MD, presented the findings in the third of three Late-Breaking Clinical Trials sessions at the VIVA22 conference held by the VIVA Foundation on October 31 to November 3 in Las Vegas, Nevada.

As summarized in the VIVA Foundation press release, the trial randomized a total of 455 patients to either treatment with the AFX/AFX2 stent graft using anatomic fixation with Duraply (n = 235) or treated with a stent graft using proximal fixation (n = 220). Demographic and anatomic characteristics were similar between the groups.

The comparative proximal fixation devices included Endurant (Medtronic; n = 91), Excluder (Gore & Associates; n = 72), and Zenith (Cook Medical; n = 57).

Patients were followed for 5 years, and an independent core lab was utilized. All device-related events and major adverse events were reviewed and adjudicated by an independent physician.

Dr. Kwolek reported that at 5 years, there was no difference between the anatomic and proximal fixation groups with respect to aneurysm-related mortality, aneurysm rupture, all-cause mortality, reintervention, or limb occlusion.

Freedom from open conversion was statistically lower for the AFX group at 100% versus 98% for the proximal fixation group (P = .0142).

The primary endpoint was aneurysm-related complications (ARCs) combined with the following: periprocedural death, aneurysm rupture, open conversion, any type of endoleak (I, II, III, IV), limb occlusion, migration > 10 mm, sac enlargement > 5 mm, and device-related reintervention.

Freedom from ARCs was higher at 5 years for the AFX group versus the proximal fixation group (63.8% vs 55.5%) and was predominantly driven by the higher type II endoleak rate seen in the proximal fixation group.

In summary, the findings showed that all four devices were effective for preventing aneurysm rupture and aneurysm-related death in over 97% of patients out to 5 years. There was no difference in type I or type III endoleaks noted, and reintervention was required in 15% of patients in both groups at 5 years with minimal need for open conversion.

With 70% of patients still alive at 5 years, further follow-up will be necessary to determine long-term outcomes, noted the VIVA Foundation press release.